B·R·A·H·M·S GmbH

Certificate HX 1333941-1

Rev. Rev. 6Restricted

Valid until: Mar 20, 2028

Certificate HX 1333941-1 is a valid Quality management system issued to B·R·A·H·M·S GmbH and registered in EUDAMED. Valid until March 20, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1333941-1
Certificate type: Quality management system
Certificate status: Restricted
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 5
Certificate ID: 0197HX 1333941-1Rev. 6

Validity

Issued: Nov 12, 2025
Valid from: Nov 12, 2025
Valid until: Mar 20, 2028

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Restricted

Supersedes

HX 1333941-1Quality management systemSupplementedOct 14, 2025 → Mar 20, 2028

Scope coverage

IVDR Class C5IVDR Class B2

7 scopes

IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020410 - THYROID STIMULATING HORMONE
IVDR Class B
IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020409 - THYROID BINDING GLOBULIN W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020390 - OTHER TUMOUR MARKERS W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01020603 - BONE AND MINERAL METABOLISM ASSAYS
IVDR Class C
IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021399 - CARDIAC MARKERS – OTHER
IVDR Class C
IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021301 - BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER
IVDR Class C
IVR 0601: Devices intended to be used for screening/confirmation of specific disorders/impairments W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
IVDR Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030609 - INTERLEUKIN 6 (IL-6) W01030608 - CYTOKINES CALIBRATORS/CONTROLS
IVDR Class C

Documents

LanguagesEN

Scope coverage

IVDR Class C5IVDR Class B2

7 scopes

IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020410 - THYROID STIMULATING HORMONE
IVDR Class B
IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020409 - THYROID BINDING GLOBULIN W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020390 - OTHER TUMOUR MARKERS W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01020603 - BONE AND MINERAL METABOLISM ASSAYS
IVDR Class C
IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021399 - CARDIAC MARKERS – OTHER
IVDR Class C
IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021301 - BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER
IVDR Class C
IVR 0601: Devices intended to be used for screening/confirmation of specific disorders/impairments W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
IVDR Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030609 - INTERLEUKIN 6 (IL-6) W01030608 - CYTOKINES CALIBRATORS/CONTROLS
IVDR Class C

Certificate HX 1333941-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HX 1333941-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer